Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Cystaran (cysteamine ophthalmic solution) 0.44% Recalled by Leadiant Biosciences, Inc. Due to Subpotent Drug: Product testing identified a decreased level...

Date: September 24, 2020
Company: Leadiant Biosciences, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Leadiant Biosciences, Inc. directly.

Affected Products

Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01

Quantity: 1380 bottles

Why Was This Recalled?

Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.

Where Was This Sold?

This product was distributed to 1 state: PA

Affected (1 state)Not affected

About Leadiant Biosciences, Inc.

Leadiant Biosciences, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report